CE mark is required for each medical device sold in EU. Since 26th May 2021 all new devices put on the market shall comply with the applicable requirements of EU medical device regulation. Although the transitional period can be used for current MDD certificates for Class III, Class IIb and Class IIa until 2024 and …
MDR Technical documentation requirements will be one of the main challenges for the medical device manufacturers during transition from 93/42/EEC (MDD) to EU 2017/745 (MDR). As explained on “How to CE Mark your medical device” article, preparation of the technical file is a critical milestone. Since there is no grandfathering for the devices on the …
EU Commission has announced EU MDR 2017/745 designation of 40th notified body (NB). The number of Notified Bodies is expected to increase with the issue of the amendment for MDR extension on 20 March 2023 .With increasing number of NBs manufacturers may find more options to certify their devices. Since beginning of 2019, when the …
European Commission published the official text of the proposal to extend the MDR transition period for legacy devices on 6 January 2023. The amendment has been formally adopted by both the European Parliament and the Council on 15 March 2023.On 20 March 2023,it has been published in the Official Journal and entered into force. As …
MDCG 2023-3-The guidance document on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices has been published by MDCG. The purpose of this guidance is to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). This …
The increased validation requirements of MDR (EU 2017/745) bring new challenges to the manufacturers of devices utilizing software and standalone software which are considered as medical device in line with the Article 2 of the MDR. EN/IEC 62304:2006/A1:2015 is a basis standard which defines requirements for Medical Device Software Life Cycle Processes. In addition …
MDR Clinical Evaluation Requirements including clinical investigation are defined on Chapter VI, Annex XIV and Annex XV respectively. As you know, to CE Mark a medical device under MDR, the importance of obtaining clinical data and evaluation is extremely important. Especially for implantable and Class III devices manufacturers shall implement a very carefully designed PMCF …
The guidance document MDCG 2020-21– Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 which is highly anticipated has been published on 16 December 2022 by MDCG. The guidance document, which provides information about the content, format and frequency of preparation for the PSUR, which must be prepared during and after the …
ISO 14644-4 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up has been revised. ISO made some changes by renewing the standard, which was first published in 2001, at the end of last month. The main changes in the new version are as follows: 1. The normative content has been expanded;2. Added …
After the issue of implementing regulation for the reprocessing of single-use devices, EU Commission issued the implementing regulation 2022/2346 as regards common specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI of EU 2017/745 MDR. The manufacturers who aim to produce the products covered by Annex XVI …